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Institutional Review Boards must comply with the Code of Federal Regulations in their written procedures but they have some flexibility with regard to the format and content, according to new HHS guidance. Read More
The FDA issued a final guidance clarifying the term “outsourcing facility” and detailing requirements for compounders operating under 503A that are next to an outsourcing facility. Read More
Australia’s Therapeutic Goods Administration revised its guidelines for confidentiality obligations and conflicts of interest for members of advisory committees, overhauling the guidance with major content and structural changes. Read More
The FDA’s draft guidance on inclusion of pregnant women in clinical trials needs some fine tuning, according to stakeholders, including more clarity on non-adherence to therapies. Read More
In an effort to curb the “gaming tactics” that delay generic drug competition, the FDA released a public list of companies found to be potentially restricting access to samples of their branded products. Read More
The FDA released the ICH’s Q12 draft guidance on pharmaceutical product lifecycle management (PLCM) for post-approval changes in chemistry, manufacturing and controls. Read More
In trials for high-risk women, the FDA recommends only superiority designs because the historical evidence of prevention efficacy in at-risk women makes determining a non-inferiority margin difficult to impossible. Read More
A 2014 court ruling found that any drug is entitled to an exclusivity period if it has been designated as an orphan drug for a qualifying condition or disease and also approved for marketing. Read More